Stephen Horrillo v. Cook Incorporated, 664 F. App'x 874

Margaret Horrillo received a biliary stent manufactured by Cook; her physician used the stent off-label to clear a renal artery. Mrs. Horrillo later died; her son Stephen Horrillo sued Cook alleging negligence, strict liability, and breach of warranty.
Trial lasted about fifteen days over nearly four weeks; the jury returned a verdict for Cook. Horrillo moved for JNOV or a new trial; the district court denied the motions.
Horrillo sought to introduce on rebuttal evidence from a post-incident clinical trial of Cook’s renal stent showing four patients suffered strokes; the district court excluded that evidence.
Horrillo also sought to admit a later warning label from Cook’s renal stent as a subsequent remedial measure; the district court excluded the label under Fed. R. Evid. 407 and as irrelevant and prejudicial.
The district court found the evidence at trial overwhelmingly supported Cook: it did not promote off-label renal use, was unaware of stroke risk from that use at the time, did not breach any duty to warn, and did not cause Mrs. Horrillo’s injury.
Horrillo appealed the evidentiary rulings, the denial of post-verdict relief, and the jury instructions/three-question verdict form; the appellate court affirmed.

Issue	Plaintiff's Argument	Defendant's Argument	Held
Admissibility of post-incident renal-stent clinical-trial stroke evidence on rebuttal	Evidence of strokes in later trial is admissible rebuttal and bears on causation/warning	Evidence is irrelevant, prejudicial, and not opened by Cook’s case; not proper rebuttal	Excluded: irrelevant and unduly prejudicial; no gateway opened for rebuttal evidence
Admissibility of later renal-stent warning label as subsequent remedial measure	Label shows knowledge/need to warn and is probative of defect/failure to warn	Excluded by Fed. R. Evid. 407; irrelevant, more prejudicial than probative, cumulative	Excluded: barred as subsequent remedial measure and also irrelevant/prejudicial
Motion for JNOV / new trial — sufficiency and weight of evidence	Verdict against great weight of evidence; JNOV or new trial warranted	Trial evidence supported verdict for Cook; reasonable jurors could find for defendant	Denied: substantial evidence supported jury; no legal basis for JNOV and no clear abuse denying new trial
Jury instructions and three-question verdict form	Alleged instructions/verdict form were misleading or confusing	Instructions and form accurately reflected law and issues	Affirmed: instructions and form accurate and not misleading

Piamba Cortes v. Am. Airlines, Inc., 177 F.3d 1272 (11th Cir. 1999) (standard for reviewing evidentiary rulings and prejudice)
Fid. Interior Const., Inc. v. Se. Carpenters Reg’l Council of United Bhd. of Carpenters & Joiners of Am., 675 F.3d 1250 (11th Cir. 2012) (abuse-of-discretion definition)
Lipphardt v. Durango Steakhouse of Brandon, Inc., 267 F.3d 1183 (11th Cir. 2001) (new-trial standard: verdict against great weight of evidence)
Wolff v. Allstate Life Ins. Co., 985 F.2d 1524 (11th Cir. 1993) (JNOV standard; consider evidence and inferences for nonmoving party)
Boeing Co. v. Shipman, 411 F.2d 365 (5th Cir. 1969) (en banc) (framework for JNOV review)
McNely v. Ocala Star-Banner Corp., 99 F.3d 1068 (11th Cir. 1996) (standard for reviewing special interrogatory verdict forms and jury instructions)
Schafer v. Time Inc., 142 F.3d 1361 (11th Cir. 1998) (deferential review of jury instructions)
Johnson v. Breeden, 280 F.3d 1308 (11th Cir. 2002) (instructions evaluated for accurate reflection of law)
Williams v. City of Valdosta, 689 F.2d 964 (5th Cir. 1982) (trial judge may grant new trial when verdict contrary to great weight of evidence)